The following data is part of a premarket notification filed by Greiner Bio-one Gmbh with the FDA for Blood Specimen Collection Devices - Vacuum.
| Device ID | BK030032 |
| 510k Number | BK030032 |
| Device Name: | Blood Specimen Collection Devices - Vacuum |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Greiner Bio-One GmbH 4238 Capital Drive Monroe, NC 28112 US |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-21 |
| Decision Date | 2003-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 39120017579947 | BK030032 | 000 |
| 39120017570869 | BK030032 | 000 |
| 39120017571026 | BK030032 | 000 |
| 39120017571095 | BK030032 | 000 |
| 39120017571163 | BK030032 | 000 |
| 39120017571217 | BK030032 | 000 |
| 39120017571248 | BK030032 | 000 |
| 39120017576281 | BK030032 | 000 |
| 39120017576342 | BK030032 | 000 |
| 39120017576359 | BK030032 | 000 |
| 39120017579121 | BK030032 | 000 |
| 39120017579923 | BK030032 | 000 |
| 39120017579930 | BK030032 | 000 |
| 39120017577172 | BK030032 | 000 |